When Arizona congresswoman Gabrielle Giffords was shot in the head at a Tucson rally in January 2011, doctors had to remove nearly half of her skull in an operation called a cranioplasty, which allows the brain tissue to swell so that it isn’t contained under life-threatening pressure. While the piece of Giffords’ skull was missing, she had to wear a protective helmet to shield her brain from further injury.
In a later surgery, doctors replaced the missing portion of her skull with an implant called a bone flap. The implant tucks under the scalp so that hair can grow on top of it, making it generally unnoticeable.
Thanks to 3D printing technology, doctors will now have the capability to construct 3D customized skull implants for patients with exposed brain tissue and missing skull bone pieces. The implants can be created within two weeks of the surgery date using a 3D printer outfitted with an orthopedic implant material called polyetherketoneketone (PEKK). The implants can safely replace as much as 75 percent of a person’s existing skull bone tissue.
Oxford Performance Materials, a company based in South Windsor, Conn., received approval for the technology from the Food and Drug Administration on February 18. The first successful operation with the implant in the U.S. took place on March 4, although the company had already been selling implants overseas as a contract manufacturer.
Scott DeFelice, president of Oxford Performance Materials, says that his company plans to continue submitting 3D printed bone parts to the FDA for approval. DeFelice estimates a potential of $50 to $100 million in revenue for each bone replacement type.
The journal Neurologic Clinics reports that two million people in the U.S. experience head injuries each year, including skull and facial fractures.
Many less serious skull fractures heal on their own. However, two types of skull fractures, depressed and compound fractures, actually cause the bone to either press inward toward brain tissue or to splinter into pieces.
Injuries to the skull can cause brain damage either through direct injury to the nervous tissue or through blood clots that form beneath the skull and put pressure on the brain. Causes of skull fractures include head trauma, falls, automobile accidents, sports injuries, diseases and physical assault.
Oxford takes a digitally scanned 3D image of a person’s skull and then gradually prints out the 3D implant layer by layer. The precision allows the creation of edge and surface details that can encourage healthy bone to attach to the implant.In the U.S., DeFelice estimates that 300 to 500 patients need skull bone replacements each month.
“We see no part of the orthopedic industry being untouched by this,” he said.
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